NCT04723537

Upamostat, a Serine Protease Inhibitor, or Placebo for Treatment of COVID-19 Disease

Phase 2/3 Study of Upamostat, a Serine Protease Inhibitor, or Placebo for Treatment of COVID-19 Disease

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: RedHill Biopharma Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A 2-part, multicenter, Phase 2/3, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of upamostat in adult patients with COVID-19 disease who do not require inpatient care.

Detailed description

Patients will be seen in a medical facility (ER or COVID-19 clinic) for initial evaluation. Consenting, diagnostically-confirmed COVID-19 patients not in need of hospitalization per investigator assessment and who meet all other inclusion and exclusion criteria will be randomized to treatment and provided with medication and home monitoring devices, and instructed in drug administration and use of the devices. They will take medication daily for two weeks, complete a smartphone-based questionnaire, provide additional monitoring information via devices provided periodically over an 8-week period. Patients will be seen at home by a study nurse or return to the clinic after 2, 4 and 8 weeks on study ("follow up" visits); additional televisits will also be conducted. At the follow up visits nasal swab specimens for COVID-19 PCR and blood specimens for safety labs and disease markers will be collected. In part A of the study, patients will be randomized 1:1:1 to one of two doses of upamostat or placebo. Based on safety results of part A, a dose for part B will be selected, and patients will be randomized 3:2 to active vs placebo.

Conditions

• Covid19

Interventions

Type	Name	Description
DRUG	Part A: Upamostat 200 mg	1 capsule comprising 200 mg of upamostat and 1 capsule comprising matching placebo.
DRUG	Part A: Upamostat 400 mg	2 capsules, each capsule comprising 200 mg of upamostat
DRUG	Part A and B: Placebo	1 or 2 capsules, each capsule a matching placebo
DRUG	Part B: Upamostat 200 or 400 mg	Based on dose selection from Part A, "Part B Upamostat" will be EITHER a single 200 mg dose of upamostat OR two 200 mg doses of upamostat, for a total of 14 days.

Timeline

• Start date: 2021-02-16
• Primary completion: 2021-12-28
• Completion: 2021-12-28
• First posted: 2021-01-25
• Last updated: 2024-06-06
• Results posted: 2024-06-06

Locations

17 sites across 2 countries: United States, South Africa

Regulatory

• FDA-regulated drug study